RECRUITING

Efficacy of a Novel Prototype Gastrostomy Tube Anchor Dressing

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a single-center prospective study evaluating the efficacy of a prototype gastrostomy anchor dressing for use with button gastrostomy tubes. The anchor dressing has been previously evaluated for usability by parents, patients, and nurses. This study compares several outcomes related to complications from gastrostomy tube placement using a prospective cohort of patients and a retrospective analysis of complications associated with gastrostomy tubes. Prospective patients will initially be monitored until they have completed their last dressing change or for a maximum of 50 days. They will then complete their final survey. Their charts will be reviewed for up to one year from their initial gastrostomy placement. The study's primary objective is to determine if the novel gastrostomy tube anchor dressing reduces rates of gastrostomy tube dislodgement and ED/clinic visits for gastrostomy tube complications.

Official Title

Efficacy of a Novel Prototype Gastrostomy Tube Anchor Dressing

Quick Facts

Study Start:2024-09-24
Study Completion:2027-12-18
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07115134

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:7 Years to 21 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients who are undergoing gastrostomy tube placement or are within five days post-operatively of gastrostomy tube placement.
  1. * 1. Patients with a skin condition that limits the placement of the dressing, this will be confirmed with the clinical team

Contacts and Locations

Study Contact

Anthony Sandler
CONTACT
202-476-5760
asandler@childrensnational.org

Study Locations (Sites)

Children's National Hospital
Washington, District of Columbia, 20010
United States

Collaborators and Investigators

Sponsor: Children's National Research Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-24
Study Completion Date2027-12-18

Study Record Updates

Study Start Date2024-09-24
Study Completion Date2027-12-18

Terms related to this study

Additional Relevant MeSH Terms

  • Gastroenterology Surgery
  • Tube Feeding